Live Webinar On Design Controls: What To Know When It Comes To Fda Regulated Industry? By Salim Khan

By:


Areas Covered in the Session:



- Medical Device, FDA & CFR

- Design Control Introduction

- Design & Development Planning

- Design Input

- Design Output

- Design Review

- Design Verification

- Design Validation

- Design Transfer

- Design Changes

- Design History File



Hear from Multiple speakers Salim Khan & Jasmin NUHIC to know the Design Controls: What to know when it comes to FDA regulated industry


Who will benefit:



- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Product development engineers

- Consultants



Free Handouts: Medical Device, FDA & CFR



Why should you Attend



In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well design - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. They have been number of FDA finds and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures. This topic is becoming ever increasing as we are being pressured to design faster, transfer faster, make faster yet never compromised quality, compliance, risk, or profit.


Meet You Speaker:



Salim Khan: He holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.


About the Author:

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information



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